The United States approved the use of boosters of Pfizer’s Covid-19 vaccine for persons over 65, adults at high risk of severe disease, and those working in high-exposure jobs on Wednesday.
The announcement means that millions of Americans, or a large portion of the population, will be eligible for a third shot six months following their second.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” said Janet Woodcock, acting head of the Food and Drug Administration, in a statement.
After an independent expert group created by the regulatory agency last week voted in favour of recommending the change, the result was expected.
The panel, on the other hand, rejected the White House’s initial intention to completely approve Pfizer boosters for everyone aged 16 and up, in a rare rebuke of President Joe Biden’s administration.
Younger adults, particularly young boys who are more susceptible to myocarditis, had a different benefit-risk balance, according to the group of vaccinologists, infectious disease specialists, and epidemiologists.
More boosters debated
Pfizer Covid-19 boosters are presently being debated by a separate panel of specialists organised by the Centers for Disease Control and Prevention (CDC), which may recommend additional recipient specifications.
If obesity is defined as placing a person “at high risk of severe Covid,” it would apply to more than 42 percent of the US population over the age of 20.
The CDC may also need to specify whether workplaces and other environments are likely to result in “frequent institutional or occupational exposure to SARS-CoV-2.”
For its part, the FDA indicated this would cover “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”
For the high risk of serious disease and high-exposure categories, the FDA’s emergency use authorisation (EUA) applies to persons aged 18 and higher. It is also limited to Pfizer’s vaccine.
Recipients of the other US-approved vaccinations, Moderna and Johnson & Johnson, will now await word on when they will be eligible for another dose.
Several investigations have found that two doses of Pfizer or Moderna, or a single shot of J&J, continue to provide high protection against severe outcomes, but this is slightly reduced in the elderly.
The World Health Organization has asked for a halt to the distribution of booster vaccines in wealthier countries, despite the fact that many countries, particularly those in Africa, have only recently launched their immunisation campaigns.
The US, on the other hand, claims that it is conceivable to support middle- and lower-income countries while simultaneously protecting its own vulnerable citizens.
President Biden stated on Wednesday that the US would purchase 500 million more Pfizer doses for the globe, bringing its total contribution to 1.1 billion.
Anthony Fauci, a top government scientist, said on Sunday that additional research is needed before deciding whether or not a booster shot is necessary for the general public.
“As we said in the beginning, we would want to plan for the possibility of vaccinating all those who have gotten their initial vaccination with Pfizer,” Fauci said. “And it was always pending the evaluation of all of the totality of the data from the United States, from Israel, and any bit of data that we could get by the advisory committee to the FDA.”
“In the right deliberation process, they came up with a recommendation,” Fauci said, adding that the FDA panel voted against a third shoot for everyone aged 16 and up. Before the meeting ends early next week, no decision will be made.